RecruitingNot ApplicableNCT05005026

Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury

A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury


Sponsor

Texas A&M University

Enrollment

250 participants

Start Date

Nov 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • The study will recruit individuals with complete injury (American Spinal Injury Association \[ASIA\] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:
  • Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
  • Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
  • Must be 18 years of age or older
  • Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
  • Must have mobile connectivity with usable service
  • Must be stable on pain medication for 1 or more months
  • Must be cleared on the VRWalk physical activity clearance scale
  • Must not have motion sickness that interferes with daily life

Exclusion Criteria7

  • Individuals with Injury levels between C1 and C4
  • Individuals under the age of 18
  • Individuals who were injured within the past year
  • Individuals who cannot comprehend spoken English
  • Individuals who are in prison
  • Individuals who are blind
  • Individuals who experience severe motion sickness

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Interventions

OTHERVR Game 1

Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

OTHERVR Game 2

Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.


Locations(3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Texas A&M University

College Station, Texas, United States

University of New South Wales

Sydney, New South Wales, Australia

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NCT05005026


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